✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
About This Trial
The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful.
The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene.
The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink.
In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day.
The participants are in the study for as long as they benefit from and can tolerate treatment.
Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.
Who Can Join?
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must show presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. * Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (ECOG=2 only for Cohorts 6, 7 and 9) . * Availability and patient willingness to provide a sample of tumour for confirmation of the patientΒ΄s Human epidermal growth factor receptor 2 (HER2) status. This sample can be archival material obtained at any time prior to study enrollment. * Patient willing and able to comply with the protocol requirements for tumour biopsies (biopsies from brain metastases are not allowed). * Adequate organ function defined as all of the following: * Absolute neutrophil count (ANC) β₯ 1.5 x 10^9/L (β₯ 1.5 x 10^3/ΞΌL) (β₯ 1500/mm^3); haemoglobin β₯ 9.0 g/dL (β₯ 90 g/L) (β₯ 5.6…
⚠ Always speak to your doctor before applying to any clinical trial.